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Orbital, over rotational, atherectomy holds survival edge in elderly, obese
WASHINGTON – Orbital atherectomy (OA) was associated with a lower risk of in-hospital mortality than rotational atherectomy (RA) in female, obese, and elderly study groups, according to data from a prospective observational study.
Each procedure was employed to treat coronary artery calcifications (CAC) in the elderly and the obese prior to percutaneous interventions (PCI).
The data comparing OA with RA in these populations were drawn from the Clinical Outcomes of Atherectomy Prior to PCI (COAP) study, for which Perwaiz M. Meraj, MD, director of structural heart and peripheral vascular disease at the North Shore-LIJ Hospital, Manhasset, N.Y., served as the senior author.
Each set of data, as well as a third set of data comparing OA to RA in female patients, was presented separately at CRT 2017, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
In the comparison of OA to RA in the elderly, a substudy known as COAP-75, the focus was on patients 75 years of age or older who underwent either OA or RA to remove calcified coronary lesions within the context of PCI. As with the obese and female subgroups, the elderly patients in this study were drawn from 35,590 patients who underwent PCI at one of five tertiary care hospitals in a recent 5-year period.
Of the 310 elderly patients undergoing atherectomy, 117 were treated with OA and 193 with RA. The median lesion lengths and diameters were not significantly different between the two groups. Although OA was less likely to be performed through femoral access (53% vs. 68.9%; P = .005), no other measured differences in procedure were significant, with one exception: Fluoroscopy exposure was of shorter duration in the OA, versus the RA, arm (24.0 minutes vs. 29.4 minutes; P = .005).
On univariate analysis, the lower rate of in-hospital deaths for OA did not reach statistical significance (0% vs. 1.55%; P = .176), but the difference was significant on multivariate-adjusted analysis (P = .034).
There were also higher numerical rates of perforation, tamponade, heart failure, and red blood cell transfusion in the RA group, versus the OA group, but only the latter was significant (P = .002) on multivariate-adjusted analysis.
In contrast, there was a higher rate of MI among those treated with OA, rather than RA (17.1% vs. 13.5%), which was not significant on univariate analysis (P = .573) but did reach significance on adjusted-multivariate analysis (P = .008).
Overall, the authors suggested that both OA and RA are safe procedures, but the mortality reduction suggests a potential relative advantage for OA.
Similar conclusions were reached in the substudy of patients with obesity, called COAP-BMI. In that study, 222 patients were evaluated, of which 91 were treated with OA and 131 were treated with RA.
In-hospital mortality was 0% in the group treated with OA, compared with 3.05% in the group treated with RA (P = .004). The rate of in-hospital major adverse cardiovascular events was also significantly lower in the OA group (15.4% vs. 16.3%; P = .007).
“The rate of secondary outcomes for myocardial infarction and stroke were similar between groups, as were individual procedural safety endpoints, including dissection, perforation, tamponade, or heart failure,” reported Evan Shlofmitz, MD, a cardiology fellow at Northwell Health, Manhasset, N.Y., who collaborated with Dr. Meraj and presented the data at the meeting.
As with the study in the elderly, for which Dr. Shlofmitz was also a coauthor, the study in the obese is the first to compare OA and RA, he noted.
In a third substudy, called COAP-Female, OA and RA were compared in 247 women with CAC who were undergoing PCI.
Again, in-hospital mortality rates were higher in those treated with RA, compared with OA, but the difference was not significant (0.79% vs. 0%; P = .254). There were also no significant differences in any secondary outcomes, including MI, or in any procedural complications, such as rates of dissection, perforation, or major bleeding.
The only significant difference identified in the study was a lower fluoroscopy time in those treated with OA relative to RA (21.3 minutes vs. 27.6 minutes; P = .001).
Although fluoroscopy time was not a primary endpoint, “a reduction in radiation exposure has important ramifications for both patients and operators,” Dr. Shlofmitz noted. He suggested that objective data on outcomes in females is needed, because this group has been “severely underrepresented in atherectomy trials.”
Overall, the substudies reinforce a large body of evidence that atherectomy is safe and effective for achieving revascularization in patients undergoing PCI who have CAC, Dr. Shlofmitz concluded. However, the significant mortality advantage for OA relative to RA in the elderly and the obese suggests that the approaches may not be interchangeable.
Dr. Shlofmitz reported no financial relationships to disclose.
WASHINGTON – Orbital atherectomy (OA) was associated with a lower risk of in-hospital mortality than rotational atherectomy (RA) in female, obese, and elderly study groups, according to data from a prospective observational study.
Each procedure was employed to treat coronary artery calcifications (CAC) in the elderly and the obese prior to percutaneous interventions (PCI).
The data comparing OA with RA in these populations were drawn from the Clinical Outcomes of Atherectomy Prior to PCI (COAP) study, for which Perwaiz M. Meraj, MD, director of structural heart and peripheral vascular disease at the North Shore-LIJ Hospital, Manhasset, N.Y., served as the senior author.
Each set of data, as well as a third set of data comparing OA to RA in female patients, was presented separately at CRT 2017, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
In the comparison of OA to RA in the elderly, a substudy known as COAP-75, the focus was on patients 75 years of age or older who underwent either OA or RA to remove calcified coronary lesions within the context of PCI. As with the obese and female subgroups, the elderly patients in this study were drawn from 35,590 patients who underwent PCI at one of five tertiary care hospitals in a recent 5-year period.
Of the 310 elderly patients undergoing atherectomy, 117 were treated with OA and 193 with RA. The median lesion lengths and diameters were not significantly different between the two groups. Although OA was less likely to be performed through femoral access (53% vs. 68.9%; P = .005), no other measured differences in procedure were significant, with one exception: Fluoroscopy exposure was of shorter duration in the OA, versus the RA, arm (24.0 minutes vs. 29.4 minutes; P = .005).
On univariate analysis, the lower rate of in-hospital deaths for OA did not reach statistical significance (0% vs. 1.55%; P = .176), but the difference was significant on multivariate-adjusted analysis (P = .034).
There were also higher numerical rates of perforation, tamponade, heart failure, and red blood cell transfusion in the RA group, versus the OA group, but only the latter was significant (P = .002) on multivariate-adjusted analysis.
In contrast, there was a higher rate of MI among those treated with OA, rather than RA (17.1% vs. 13.5%), which was not significant on univariate analysis (P = .573) but did reach significance on adjusted-multivariate analysis (P = .008).
Overall, the authors suggested that both OA and RA are safe procedures, but the mortality reduction suggests a potential relative advantage for OA.
Similar conclusions were reached in the substudy of patients with obesity, called COAP-BMI. In that study, 222 patients were evaluated, of which 91 were treated with OA and 131 were treated with RA.
In-hospital mortality was 0% in the group treated with OA, compared with 3.05% in the group treated with RA (P = .004). The rate of in-hospital major adverse cardiovascular events was also significantly lower in the OA group (15.4% vs. 16.3%; P = .007).
“The rate of secondary outcomes for myocardial infarction and stroke were similar between groups, as were individual procedural safety endpoints, including dissection, perforation, tamponade, or heart failure,” reported Evan Shlofmitz, MD, a cardiology fellow at Northwell Health, Manhasset, N.Y., who collaborated with Dr. Meraj and presented the data at the meeting.
As with the study in the elderly, for which Dr. Shlofmitz was also a coauthor, the study in the obese is the first to compare OA and RA, he noted.
In a third substudy, called COAP-Female, OA and RA were compared in 247 women with CAC who were undergoing PCI.
Again, in-hospital mortality rates were higher in those treated with RA, compared with OA, but the difference was not significant (0.79% vs. 0%; P = .254). There were also no significant differences in any secondary outcomes, including MI, or in any procedural complications, such as rates of dissection, perforation, or major bleeding.
The only significant difference identified in the study was a lower fluoroscopy time in those treated with OA relative to RA (21.3 minutes vs. 27.6 minutes; P = .001).
Although fluoroscopy time was not a primary endpoint, “a reduction in radiation exposure has important ramifications for both patients and operators,” Dr. Shlofmitz noted. He suggested that objective data on outcomes in females is needed, because this group has been “severely underrepresented in atherectomy trials.”
Overall, the substudies reinforce a large body of evidence that atherectomy is safe and effective for achieving revascularization in patients undergoing PCI who have CAC, Dr. Shlofmitz concluded. However, the significant mortality advantage for OA relative to RA in the elderly and the obese suggests that the approaches may not be interchangeable.
Dr. Shlofmitz reported no financial relationships to disclose.
WASHINGTON – Orbital atherectomy (OA) was associated with a lower risk of in-hospital mortality than rotational atherectomy (RA) in female, obese, and elderly study groups, according to data from a prospective observational study.
Each procedure was employed to treat coronary artery calcifications (CAC) in the elderly and the obese prior to percutaneous interventions (PCI).
The data comparing OA with RA in these populations were drawn from the Clinical Outcomes of Atherectomy Prior to PCI (COAP) study, for which Perwaiz M. Meraj, MD, director of structural heart and peripheral vascular disease at the North Shore-LIJ Hospital, Manhasset, N.Y., served as the senior author.
Each set of data, as well as a third set of data comparing OA to RA in female patients, was presented separately at CRT 2017, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
In the comparison of OA to RA in the elderly, a substudy known as COAP-75, the focus was on patients 75 years of age or older who underwent either OA or RA to remove calcified coronary lesions within the context of PCI. As with the obese and female subgroups, the elderly patients in this study were drawn from 35,590 patients who underwent PCI at one of five tertiary care hospitals in a recent 5-year period.
Of the 310 elderly patients undergoing atherectomy, 117 were treated with OA and 193 with RA. The median lesion lengths and diameters were not significantly different between the two groups. Although OA was less likely to be performed through femoral access (53% vs. 68.9%; P = .005), no other measured differences in procedure were significant, with one exception: Fluoroscopy exposure was of shorter duration in the OA, versus the RA, arm (24.0 minutes vs. 29.4 minutes; P = .005).
On univariate analysis, the lower rate of in-hospital deaths for OA did not reach statistical significance (0% vs. 1.55%; P = .176), but the difference was significant on multivariate-adjusted analysis (P = .034).
There were also higher numerical rates of perforation, tamponade, heart failure, and red blood cell transfusion in the RA group, versus the OA group, but only the latter was significant (P = .002) on multivariate-adjusted analysis.
In contrast, there was a higher rate of MI among those treated with OA, rather than RA (17.1% vs. 13.5%), which was not significant on univariate analysis (P = .573) but did reach significance on adjusted-multivariate analysis (P = .008).
Overall, the authors suggested that both OA and RA are safe procedures, but the mortality reduction suggests a potential relative advantage for OA.
Similar conclusions were reached in the substudy of patients with obesity, called COAP-BMI. In that study, 222 patients were evaluated, of which 91 were treated with OA and 131 were treated with RA.
In-hospital mortality was 0% in the group treated with OA, compared with 3.05% in the group treated with RA (P = .004). The rate of in-hospital major adverse cardiovascular events was also significantly lower in the OA group (15.4% vs. 16.3%; P = .007).
“The rate of secondary outcomes for myocardial infarction and stroke were similar between groups, as were individual procedural safety endpoints, including dissection, perforation, tamponade, or heart failure,” reported Evan Shlofmitz, MD, a cardiology fellow at Northwell Health, Manhasset, N.Y., who collaborated with Dr. Meraj and presented the data at the meeting.
As with the study in the elderly, for which Dr. Shlofmitz was also a coauthor, the study in the obese is the first to compare OA and RA, he noted.
In a third substudy, called COAP-Female, OA and RA were compared in 247 women with CAC who were undergoing PCI.
Again, in-hospital mortality rates were higher in those treated with RA, compared with OA, but the difference was not significant (0.79% vs. 0%; P = .254). There were also no significant differences in any secondary outcomes, including MI, or in any procedural complications, such as rates of dissection, perforation, or major bleeding.
The only significant difference identified in the study was a lower fluoroscopy time in those treated with OA relative to RA (21.3 minutes vs. 27.6 minutes; P = .001).
Although fluoroscopy time was not a primary endpoint, “a reduction in radiation exposure has important ramifications for both patients and operators,” Dr. Shlofmitz noted. He suggested that objective data on outcomes in females is needed, because this group has been “severely underrepresented in atherectomy trials.”
Overall, the substudies reinforce a large body of evidence that atherectomy is safe and effective for achieving revascularization in patients undergoing PCI who have CAC, Dr. Shlofmitz concluded. However, the significant mortality advantage for OA relative to RA in the elderly and the obese suggests that the approaches may not be interchangeable.
Dr. Shlofmitz reported no financial relationships to disclose.
AT CRT 2017
Key clinical point: Orbital atherectomy was associated with better survival than rotational atherectomy in elderly and obese patients requiring percutaneous interventions.
Major finding: In-hospital mortality was significantly lower after orbital atherectomy, compared with rotational atherectomy, in both the elderly (0% vs. 1.55%; P = .034) and the obese (0% vs. 3.05%; P = .004).
Data source: A nonrandomized, prospective, multicenter study.
Disclosures: Dr. Shlofmitz reported no financial relationships to disclose.
TAVR can be performed safely within 30 days of PCI
WASHINGTON – The risk of adverse events from a transcatheter aortic valve replacement (TAVR) does not appear to be significantly increased in those who have undergone a recent percutaneous intervention (PCI), according to a matched retrospective analysis.
“PCI prior to TAVR in patients with severe aortic stenosis and significant coronary artery disease appears to be feasible and safe,” reported Ashwat S. Dhillon, MD, a cardiology fellow at the University of Southern California, Los Angeles, at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The conclusion that PCI can be performed safely prior to TAVR was drawn from a series of 286 patients treated with TAVR over a nearly 5-year period. Within this group, 29 patients underwent PCI for CAD within 30 days prior to TAVR. They were matched in a 1:1 fashion based on age, sex, history of prior myocardial infarction, and left ventricular ejection fraction to patients undergoing PCI without subsequent TAVR.
The primary endpoint of the analysis was a composite of major in-hospital adverse cardiovascular events (MACE) that included MI and stroke. In addition, the two groups were compared for mortality and readmission rates 30 days after TAVR.
Most of the patients (69%) were male, and the mean age was 77 years. About 20% had a prior MI, roughly 30% had a prior coronary artery bypass graft procedure, and approximately 30% had a prior PCI. There were numerical differences in the rates of hypertension, chronic kidney disease, and diabetes when the two groups were compared, but none were statistically significant.
The procedural details of the PCI were also similar, according to Dr. Dhillon. Although there was a significantly greater proportion of patients treated for lesions in the left circumflex artery in the group that did not undergo TAVR (31.03% vs. 3.45%; P = .02), there were no significant differences in procedures performed in other arteries. There were also no significant differences in the average number of stents and the average total stent length for those who underwent TAVR relative to those who did not.
The rate of in-hospital MI was 14% in both groups. No patient in either group had a stroke. At 30 days, mortality was 3% in each group. Although 30-day readmissions were higher in the group that underwent both PCI and TAVR than those who underwent PCI alone (10% vs. 0%), the difference did not reach significance.
Data evaluating the safety of performing PCI and TAVR procedures in close proximity is needed because “a significant proportion of patients with severe aortic stenosis have coexisting and significant CAD,” Dr. Dhillon explained. Although he suggested that a larger pool of data is needed to confirm the preliminary findings of this study, he suggested that these data are reassuring.
WASHINGTON – The risk of adverse events from a transcatheter aortic valve replacement (TAVR) does not appear to be significantly increased in those who have undergone a recent percutaneous intervention (PCI), according to a matched retrospective analysis.
“PCI prior to TAVR in patients with severe aortic stenosis and significant coronary artery disease appears to be feasible and safe,” reported Ashwat S. Dhillon, MD, a cardiology fellow at the University of Southern California, Los Angeles, at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The conclusion that PCI can be performed safely prior to TAVR was drawn from a series of 286 patients treated with TAVR over a nearly 5-year period. Within this group, 29 patients underwent PCI for CAD within 30 days prior to TAVR. They were matched in a 1:1 fashion based on age, sex, history of prior myocardial infarction, and left ventricular ejection fraction to patients undergoing PCI without subsequent TAVR.
The primary endpoint of the analysis was a composite of major in-hospital adverse cardiovascular events (MACE) that included MI and stroke. In addition, the two groups were compared for mortality and readmission rates 30 days after TAVR.
Most of the patients (69%) were male, and the mean age was 77 years. About 20% had a prior MI, roughly 30% had a prior coronary artery bypass graft procedure, and approximately 30% had a prior PCI. There were numerical differences in the rates of hypertension, chronic kidney disease, and diabetes when the two groups were compared, but none were statistically significant.
The procedural details of the PCI were also similar, according to Dr. Dhillon. Although there was a significantly greater proportion of patients treated for lesions in the left circumflex artery in the group that did not undergo TAVR (31.03% vs. 3.45%; P = .02), there were no significant differences in procedures performed in other arteries. There were also no significant differences in the average number of stents and the average total stent length for those who underwent TAVR relative to those who did not.
The rate of in-hospital MI was 14% in both groups. No patient in either group had a stroke. At 30 days, mortality was 3% in each group. Although 30-day readmissions were higher in the group that underwent both PCI and TAVR than those who underwent PCI alone (10% vs. 0%), the difference did not reach significance.
Data evaluating the safety of performing PCI and TAVR procedures in close proximity is needed because “a significant proportion of patients with severe aortic stenosis have coexisting and significant CAD,” Dr. Dhillon explained. Although he suggested that a larger pool of data is needed to confirm the preliminary findings of this study, he suggested that these data are reassuring.
WASHINGTON – The risk of adverse events from a transcatheter aortic valve replacement (TAVR) does not appear to be significantly increased in those who have undergone a recent percutaneous intervention (PCI), according to a matched retrospective analysis.
“PCI prior to TAVR in patients with severe aortic stenosis and significant coronary artery disease appears to be feasible and safe,” reported Ashwat S. Dhillon, MD, a cardiology fellow at the University of Southern California, Los Angeles, at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The conclusion that PCI can be performed safely prior to TAVR was drawn from a series of 286 patients treated with TAVR over a nearly 5-year period. Within this group, 29 patients underwent PCI for CAD within 30 days prior to TAVR. They were matched in a 1:1 fashion based on age, sex, history of prior myocardial infarction, and left ventricular ejection fraction to patients undergoing PCI without subsequent TAVR.
The primary endpoint of the analysis was a composite of major in-hospital adverse cardiovascular events (MACE) that included MI and stroke. In addition, the two groups were compared for mortality and readmission rates 30 days after TAVR.
Most of the patients (69%) were male, and the mean age was 77 years. About 20% had a prior MI, roughly 30% had a prior coronary artery bypass graft procedure, and approximately 30% had a prior PCI. There were numerical differences in the rates of hypertension, chronic kidney disease, and diabetes when the two groups were compared, but none were statistically significant.
The procedural details of the PCI were also similar, according to Dr. Dhillon. Although there was a significantly greater proportion of patients treated for lesions in the left circumflex artery in the group that did not undergo TAVR (31.03% vs. 3.45%; P = .02), there were no significant differences in procedures performed in other arteries. There were also no significant differences in the average number of stents and the average total stent length for those who underwent TAVR relative to those who did not.
The rate of in-hospital MI was 14% in both groups. No patient in either group had a stroke. At 30 days, mortality was 3% in each group. Although 30-day readmissions were higher in the group that underwent both PCI and TAVR than those who underwent PCI alone (10% vs. 0%), the difference did not reach significance.
Data evaluating the safety of performing PCI and TAVR procedures in close proximity is needed because “a significant proportion of patients with severe aortic stenosis have coexisting and significant CAD,” Dr. Dhillon explained. Although he suggested that a larger pool of data is needed to confirm the preliminary findings of this study, he suggested that these data are reassuring.
AT CRT 2017
Key clinical point: Adverse outcomes from transcatheter aortic valve replacement are not increased in patients who had a recent percutaneous intervention.
Major finding: Rates of in-hospital MI (14%), stroke (0%), and 30-day mortality (3%) were exactly the same for those with or without prior PCI.
Data source: A nonrandomized, retrospective, matched analysis.
Disclosures: Dr. Dhillon reported no financial relationships to disclose.
Arteriovenous coupler for structural hypertension poised for sham-controlled study
WASHINGTON – A new device may be the best opportunity yet to achieve sustained blood pressure control in individuals aged 60 years and older, according to Paul Sobotka, MD, Chief Scientific Officer at ROX Medical, the maker of the device.
The experimental device is an arteriovenous coupler that provides an anastomosis between artery and vein to lower arterial volume and reduce blood pressure due to a structural cause. The device has already performed well in initial clinical studies, including a controlled, open-label trial, he reported at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
While neurohormonally driven elevations drive increases in diastolic and systolic blood pressures in younger patients, aortic stiffness and loss of vascular elasticity characterize the structurally driven hypertension of older patients, he said. While diuretics can lower arterial volume to achieve reductions in structurally related systolic hypertension, large doses are typically required to have meaningful results and are likely to be accompanied by unacceptable side effects in a large proportion of patients, he said.
“Somewhere between the age of 50 and 60 years, the majority of hypertensive patients will no longer be principally responsive to drugs acting on neurohormonal pathways or to renal denervation strategies.” In the elderly, cardiovascular risk is largely driven by hypertension principally related to the loss of aortic elasticity, which does not respond to most antihypertensive drugs.
The investigational arteriovenous coupler being developed by ROX Medical is intended to lower systolic blood pressure by reducing vascular resistance and therefore arterial volume. The coupler can be placed during cardiac catheterization, does not require sedation, takes about 1 hour to insert, and can be removed if necessary.
In a randomized, open-label study (Lancet. 2015 Apr;385:1634-41), mean systolic blood pressure was reduced by 26.9 mmHg on average in the 44 patients who received the arteriovenous coupler (P less than .001 vs. baseline) and by 3.7 mmHg (P = .31 vs. baseline) in the 39 patients who were maintained on antihypertensive medication, said Dr. Sobotka, who was a coauthor on this and several other clinical studies testing the efficacy and safety of the coupler. Systolic blood pressure falls almost immediately after the device is positioned, and blood pressure control has been sustained for up to 2 years of follow-up so far.
The procedure has been effective in patients resistant to antihypertensive medications and in those who have failed renal denervation, he said.
“The most significant adverse event observed has been venous stenosis related to turbulence, which occurs within in the first 12 months” after device placement, Dr. Sobotka reported. He said that venous stenting has resolved the problem in all affected patients. “Adverse events beyond that have been trivial.”
WASHINGTON – A new device may be the best opportunity yet to achieve sustained blood pressure control in individuals aged 60 years and older, according to Paul Sobotka, MD, Chief Scientific Officer at ROX Medical, the maker of the device.
The experimental device is an arteriovenous coupler that provides an anastomosis between artery and vein to lower arterial volume and reduce blood pressure due to a structural cause. The device has already performed well in initial clinical studies, including a controlled, open-label trial, he reported at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
While neurohormonally driven elevations drive increases in diastolic and systolic blood pressures in younger patients, aortic stiffness and loss of vascular elasticity characterize the structurally driven hypertension of older patients, he said. While diuretics can lower arterial volume to achieve reductions in structurally related systolic hypertension, large doses are typically required to have meaningful results and are likely to be accompanied by unacceptable side effects in a large proportion of patients, he said.
“Somewhere between the age of 50 and 60 years, the majority of hypertensive patients will no longer be principally responsive to drugs acting on neurohormonal pathways or to renal denervation strategies.” In the elderly, cardiovascular risk is largely driven by hypertension principally related to the loss of aortic elasticity, which does not respond to most antihypertensive drugs.
The investigational arteriovenous coupler being developed by ROX Medical is intended to lower systolic blood pressure by reducing vascular resistance and therefore arterial volume. The coupler can be placed during cardiac catheterization, does not require sedation, takes about 1 hour to insert, and can be removed if necessary.
In a randomized, open-label study (Lancet. 2015 Apr;385:1634-41), mean systolic blood pressure was reduced by 26.9 mmHg on average in the 44 patients who received the arteriovenous coupler (P less than .001 vs. baseline) and by 3.7 mmHg (P = .31 vs. baseline) in the 39 patients who were maintained on antihypertensive medication, said Dr. Sobotka, who was a coauthor on this and several other clinical studies testing the efficacy and safety of the coupler. Systolic blood pressure falls almost immediately after the device is positioned, and blood pressure control has been sustained for up to 2 years of follow-up so far.
The procedure has been effective in patients resistant to antihypertensive medications and in those who have failed renal denervation, he said.
“The most significant adverse event observed has been venous stenosis related to turbulence, which occurs within in the first 12 months” after device placement, Dr. Sobotka reported. He said that venous stenting has resolved the problem in all affected patients. “Adverse events beyond that have been trivial.”
WASHINGTON – A new device may be the best opportunity yet to achieve sustained blood pressure control in individuals aged 60 years and older, according to Paul Sobotka, MD, Chief Scientific Officer at ROX Medical, the maker of the device.
The experimental device is an arteriovenous coupler that provides an anastomosis between artery and vein to lower arterial volume and reduce blood pressure due to a structural cause. The device has already performed well in initial clinical studies, including a controlled, open-label trial, he reported at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
While neurohormonally driven elevations drive increases in diastolic and systolic blood pressures in younger patients, aortic stiffness and loss of vascular elasticity characterize the structurally driven hypertension of older patients, he said. While diuretics can lower arterial volume to achieve reductions in structurally related systolic hypertension, large doses are typically required to have meaningful results and are likely to be accompanied by unacceptable side effects in a large proportion of patients, he said.
“Somewhere between the age of 50 and 60 years, the majority of hypertensive patients will no longer be principally responsive to drugs acting on neurohormonal pathways or to renal denervation strategies.” In the elderly, cardiovascular risk is largely driven by hypertension principally related to the loss of aortic elasticity, which does not respond to most antihypertensive drugs.
The investigational arteriovenous coupler being developed by ROX Medical is intended to lower systolic blood pressure by reducing vascular resistance and therefore arterial volume. The coupler can be placed during cardiac catheterization, does not require sedation, takes about 1 hour to insert, and can be removed if necessary.
In a randomized, open-label study (Lancet. 2015 Apr;385:1634-41), mean systolic blood pressure was reduced by 26.9 mmHg on average in the 44 patients who received the arteriovenous coupler (P less than .001 vs. baseline) and by 3.7 mmHg (P = .31 vs. baseline) in the 39 patients who were maintained on antihypertensive medication, said Dr. Sobotka, who was a coauthor on this and several other clinical studies testing the efficacy and safety of the coupler. Systolic blood pressure falls almost immediately after the device is positioned, and blood pressure control has been sustained for up to 2 years of follow-up so far.
The procedure has been effective in patients resistant to antihypertensive medications and in those who have failed renal denervation, he said.
“The most significant adverse event observed has been venous stenosis related to turbulence, which occurs within in the first 12 months” after device placement, Dr. Sobotka reported. He said that venous stenting has resolved the problem in all affected patients. “Adverse events beyond that have been trivial.”
EXPERT ANALYSIS AT CRT 2017
When STEMI door-to-balloon times deteriorate
WASHINGTON – The interventional cardiology team at Geisinger Medical Center, Danville, Pa., reorganized their care for ST segment elevation MI (STEMI) in 2004 to improve their door-to-balloon angioplasty times. Their highly successful efforts soon streamlined the process, placing Geisinger in the top 10% nationally for low average door-to-balloon (DTB) times.
Then, Geisinger began to see their DTB times creep up.
After witnessing a 5- to 10-minute increase in DTB times for STEMI patients – whether picked up by ambulance, appearing in the emergency department (ED), or referred from neighboring hospitals – James Blankenship, MD, director of the division of cardiology, and fellow Geisinger researchers took on an institutional analysis, which was presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Their analysis failed to identify a single explanation, but it did reinforce the importance of constantly reinvigorating processes, Dr. Blankenship said. And their analysis indicated that delays don’t necessarily translate into poorer outcomes.
One proposed explanation was that delays had been caused by an increased reliance on radial rather than femoral catheter access. Dr. Blankenship cited studies suggesting that radial access increases DTB times by 1 to 12 minutes. The proportion of percutaneous coronary interventions performed radially at Geisinger had risen from 2% to 85% over the time period that DTB times had risen.
“There is evidence of benefit from radial access, so even if it slows you down a few minutes, it may be worth doing,” Dr. Blankenship noted. However, when this variable was evaluated, the DTB times were, if anything, slightly faster with radial relative to femoral access.
Another theory was that the decision to provide fellows with a greater role in STEMI management had produced treatment delays. In the cath lab at Geisinger, the increased fellow participation “correlated perfectly” with the decline in DTB times, according to Dr. Blankenship. However, a close look at this variable failed to show any meaningful impact on DTB times.
Changes in process were also examined. For one example, a form must now be completed documenting airway assessment. However, Dr. Blankenship found that filling out this form only takes about a minute and could account for only a small part of the observed loss.
The most significant cause for the increased DTB times among STEMI patients presenting in the ED may well have been a 2012 change in the configuration of the hospital. Prior to 2012, the distance from the ED to the cath lab was less than 100 yards and a 1-minute walk. After the change in the configuration, the cath lab was approximately 7 minutes away, a change that “correlated somewhat” to a prolongation in DTB times.
Similarly, regional hospital STEMI referral patterns changed when a hospital in relatively close proximity opened a cath lab. Up until that time, most referrals had been a 5-minute helicopter transfer, according to Dr. Blankenship. Afterwards, some helicopter transfer times rose to 25 minutes.
Yet, no explanation seemed to be more important than simply ensuring that new staff understand and adhere to the processes. Recounting his experience with a “secret shopper” approach in which he called Geisinger posing as a referring physician to report a potential STEMI, he was disappointed to reach a staff member uncertain of the meaning of the term STEMI.
“STEMI systems need a lot of maintenance,” Dr. Blankenship said. He cautioned that staff changes are common and frequent, making it important to continually assess whether all the participants in delivering STEMI care understand their role.
Some published studies challenge the importance of small changes in DTB times as a predictor of STEMI survival, according to Dr. Blankenship, citing one national survey unable to link a reduction in DTB times with a change in in-hospital mortality (N Engl J Med. 2013;369:901-09). However, he has been more convinced by those studies that do show a relationship. He cited one large study that found an 8% loss in the mortality benefit for each 10-minute delay in DTB (Lancet. 2015;385:1114-22).
Rapid DTB times cannot be divorced from quality of care, Dr. Blankenship said. He cited an experience at one center in which an aggressive program for reducing DTB times led to an increase in mortality among false-positive patients. “It is okay to sacrifice time for quality.”
It was at the 2016 CRT meeting that Dr. Blankenship first provided data showing the decline in DTB times at his institution. At that time and prior to the more comprehensive evaluation of the reasons for the delay presented at this year’s meeting, he speculated that it may be just a question of fatigue from sustaining a rapid response posture over several years.
“My original observation, that after a while you just get tired, is probably still true,” he said.
WASHINGTON – The interventional cardiology team at Geisinger Medical Center, Danville, Pa., reorganized their care for ST segment elevation MI (STEMI) in 2004 to improve their door-to-balloon angioplasty times. Their highly successful efforts soon streamlined the process, placing Geisinger in the top 10% nationally for low average door-to-balloon (DTB) times.
Then, Geisinger began to see their DTB times creep up.
After witnessing a 5- to 10-minute increase in DTB times for STEMI patients – whether picked up by ambulance, appearing in the emergency department (ED), or referred from neighboring hospitals – James Blankenship, MD, director of the division of cardiology, and fellow Geisinger researchers took on an institutional analysis, which was presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Their analysis failed to identify a single explanation, but it did reinforce the importance of constantly reinvigorating processes, Dr. Blankenship said. And their analysis indicated that delays don’t necessarily translate into poorer outcomes.
One proposed explanation was that delays had been caused by an increased reliance on radial rather than femoral catheter access. Dr. Blankenship cited studies suggesting that radial access increases DTB times by 1 to 12 minutes. The proportion of percutaneous coronary interventions performed radially at Geisinger had risen from 2% to 85% over the time period that DTB times had risen.
“There is evidence of benefit from radial access, so even if it slows you down a few minutes, it may be worth doing,” Dr. Blankenship noted. However, when this variable was evaluated, the DTB times were, if anything, slightly faster with radial relative to femoral access.
Another theory was that the decision to provide fellows with a greater role in STEMI management had produced treatment delays. In the cath lab at Geisinger, the increased fellow participation “correlated perfectly” with the decline in DTB times, according to Dr. Blankenship. However, a close look at this variable failed to show any meaningful impact on DTB times.
Changes in process were also examined. For one example, a form must now be completed documenting airway assessment. However, Dr. Blankenship found that filling out this form only takes about a minute and could account for only a small part of the observed loss.
The most significant cause for the increased DTB times among STEMI patients presenting in the ED may well have been a 2012 change in the configuration of the hospital. Prior to 2012, the distance from the ED to the cath lab was less than 100 yards and a 1-minute walk. After the change in the configuration, the cath lab was approximately 7 minutes away, a change that “correlated somewhat” to a prolongation in DTB times.
Similarly, regional hospital STEMI referral patterns changed when a hospital in relatively close proximity opened a cath lab. Up until that time, most referrals had been a 5-minute helicopter transfer, according to Dr. Blankenship. Afterwards, some helicopter transfer times rose to 25 minutes.
Yet, no explanation seemed to be more important than simply ensuring that new staff understand and adhere to the processes. Recounting his experience with a “secret shopper” approach in which he called Geisinger posing as a referring physician to report a potential STEMI, he was disappointed to reach a staff member uncertain of the meaning of the term STEMI.
“STEMI systems need a lot of maintenance,” Dr. Blankenship said. He cautioned that staff changes are common and frequent, making it important to continually assess whether all the participants in delivering STEMI care understand their role.
Some published studies challenge the importance of small changes in DTB times as a predictor of STEMI survival, according to Dr. Blankenship, citing one national survey unable to link a reduction in DTB times with a change in in-hospital mortality (N Engl J Med. 2013;369:901-09). However, he has been more convinced by those studies that do show a relationship. He cited one large study that found an 8% loss in the mortality benefit for each 10-minute delay in DTB (Lancet. 2015;385:1114-22).
Rapid DTB times cannot be divorced from quality of care, Dr. Blankenship said. He cited an experience at one center in which an aggressive program for reducing DTB times led to an increase in mortality among false-positive patients. “It is okay to sacrifice time for quality.”
It was at the 2016 CRT meeting that Dr. Blankenship first provided data showing the decline in DTB times at his institution. At that time and prior to the more comprehensive evaluation of the reasons for the delay presented at this year’s meeting, he speculated that it may be just a question of fatigue from sustaining a rapid response posture over several years.
“My original observation, that after a while you just get tired, is probably still true,” he said.
WASHINGTON – The interventional cardiology team at Geisinger Medical Center, Danville, Pa., reorganized their care for ST segment elevation MI (STEMI) in 2004 to improve their door-to-balloon angioplasty times. Their highly successful efforts soon streamlined the process, placing Geisinger in the top 10% nationally for low average door-to-balloon (DTB) times.
Then, Geisinger began to see their DTB times creep up.
After witnessing a 5- to 10-minute increase in DTB times for STEMI patients – whether picked up by ambulance, appearing in the emergency department (ED), or referred from neighboring hospitals – James Blankenship, MD, director of the division of cardiology, and fellow Geisinger researchers took on an institutional analysis, which was presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Their analysis failed to identify a single explanation, but it did reinforce the importance of constantly reinvigorating processes, Dr. Blankenship said. And their analysis indicated that delays don’t necessarily translate into poorer outcomes.
One proposed explanation was that delays had been caused by an increased reliance on radial rather than femoral catheter access. Dr. Blankenship cited studies suggesting that radial access increases DTB times by 1 to 12 minutes. The proportion of percutaneous coronary interventions performed radially at Geisinger had risen from 2% to 85% over the time period that DTB times had risen.
“There is evidence of benefit from radial access, so even if it slows you down a few minutes, it may be worth doing,” Dr. Blankenship noted. However, when this variable was evaluated, the DTB times were, if anything, slightly faster with radial relative to femoral access.
Another theory was that the decision to provide fellows with a greater role in STEMI management had produced treatment delays. In the cath lab at Geisinger, the increased fellow participation “correlated perfectly” with the decline in DTB times, according to Dr. Blankenship. However, a close look at this variable failed to show any meaningful impact on DTB times.
Changes in process were also examined. For one example, a form must now be completed documenting airway assessment. However, Dr. Blankenship found that filling out this form only takes about a minute and could account for only a small part of the observed loss.
The most significant cause for the increased DTB times among STEMI patients presenting in the ED may well have been a 2012 change in the configuration of the hospital. Prior to 2012, the distance from the ED to the cath lab was less than 100 yards and a 1-minute walk. After the change in the configuration, the cath lab was approximately 7 minutes away, a change that “correlated somewhat” to a prolongation in DTB times.
Similarly, regional hospital STEMI referral patterns changed when a hospital in relatively close proximity opened a cath lab. Up until that time, most referrals had been a 5-minute helicopter transfer, according to Dr. Blankenship. Afterwards, some helicopter transfer times rose to 25 minutes.
Yet, no explanation seemed to be more important than simply ensuring that new staff understand and adhere to the processes. Recounting his experience with a “secret shopper” approach in which he called Geisinger posing as a referring physician to report a potential STEMI, he was disappointed to reach a staff member uncertain of the meaning of the term STEMI.
“STEMI systems need a lot of maintenance,” Dr. Blankenship said. He cautioned that staff changes are common and frequent, making it important to continually assess whether all the participants in delivering STEMI care understand their role.
Some published studies challenge the importance of small changes in DTB times as a predictor of STEMI survival, according to Dr. Blankenship, citing one national survey unable to link a reduction in DTB times with a change in in-hospital mortality (N Engl J Med. 2013;369:901-09). However, he has been more convinced by those studies that do show a relationship. He cited one large study that found an 8% loss in the mortality benefit for each 10-minute delay in DTB (Lancet. 2015;385:1114-22).
Rapid DTB times cannot be divorced from quality of care, Dr. Blankenship said. He cited an experience at one center in which an aggressive program for reducing DTB times led to an increase in mortality among false-positive patients. “It is okay to sacrifice time for quality.”
It was at the 2016 CRT meeting that Dr. Blankenship first provided data showing the decline in DTB times at his institution. At that time and prior to the more comprehensive evaluation of the reasons for the delay presented at this year’s meeting, he speculated that it may be just a question of fatigue from sustaining a rapid response posture over several years.
“My original observation, that after a while you just get tired, is probably still true,” he said.
AT CRT 2017
Key clinical point: With small deviations in process over time, delays build in the emergency treatment of ST segment elevation MI (STEMI).
Major finding: Processes must be regularly reinvigorated, a systematic evaluation of deteriorating door-to-balloon times for STEMI care suggests.
Data source: Nonrandomized retrospective analysis.
Disclosures: Dr. Blankenship reported no financial relationships to disclose.
Prolonged dual-antiplatelet therapy after PCI challenged
WASHINGTON – Guidelines were recently modified to permit shorter duration of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention, but a series of ongoing trials are evaluating whether DAPT can be abandoned altogether in many if not most percutaneous coronary intervention (PCI) patients, according to a review of this major potential change in direction presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“The 1-year duration of dual-antiplatelet therapy post PCI with a drug eluting stent is based on anecdotal historical data,” asserted Patrick W. Serruys, MD, PhD, professor of cardiology, Imperial College, London. Citing several sets of data consistent with the conclusion that single agents provide adequate protection against thrombus formation but reduced risk of bleeding relative to DAPT, he suggested that it is now critical to challenge the old standard.
It has long been understood that greater protection against thrombus formation with more aggressive antiplatelet therapy is purchased with a higher risk of bleeding, but there appears to be a fundamental change in orientation. Several new pieces of evidence, including data showing that shorter duration of DAPT is as good as longer duration, has placed this trade-off in doubt at least over the longer term.
To some degree, the current standard was based on the premise that thrombotic events are more important than bleeding events, according to Usman Baber, MD, assistant professor of cardiology, Icahn School of Medicine at Mount Sinai, New York. He said, “That thought process really dominated thinking for many years, but this is completely unsupported by the data.” Instead, he noted that hazard ratios after thrombotic and bleeding events are almost identical, but the risk of death after bleeding is more persistent, while risk of ischemic events typically diminishes after an initial peak.
There is no shortage of studies that have attempted to determine the ideal combination and duration of antiplatelet therapies after PCI, but the heterogeneity of study design has prohibited definitive conclusions. In particular, Dr. Serruys suggested that there is no level 1 evidence confirming the value of adding aspirin, which he emphasized has a relatively nonspecific effect, over that of P2Y12 inhibitor alone.
In the design phase of the GLOBAL LEADERS trial, Dr. Serruys recounted, he first argued for a design in which aspirin was eliminated altogether and then for a protocol with only a single week of aspirin, but was met with strong objections each time. In the end, the experimental protocol calls for 1 month of aspirin plus ticagrelor before patients are continued on ticagrelor alone. This is being compared with the current standard, which is aspirin plus ticagrelor or clopidogrel for 12 months followed by another 12 months of aspirin alone.
GLOBAL LEADERS is an all-comers trial in which patients are randomized before PCI. All patients at the 131 participating centers in 18 countries are receiving the same stent (BioMatrix Flex). The primary endpoint is all-cause mortality, and enrollment is completed. The results are expected in November of this year.
There are numerous other studies addressing the same question. Like GLOBAL LEADERS, the TWILIGHT trial is also investigator-initiated and is near the halfway mark for a 9,000-patient enrollment. In this study, patients are being randomized to aspirin plus ticagrelor or ticagrelor alone after they have achieved a successful placement of a drug-eluting stent. This trial, however, is restricted to those with diabetes, chronic kidney disease, or other high-risk features. The primary endpoint is major bleeding. Completion is expected in 2019.
The SMART-CHOICE trial is enrolling roughly 5,000 PCI patients receiving a drug-eluting stent. Patients are being randomized to a P2Y12 antagonist monotherapy plus aspirin or the P2Y12 antagonist alone. The primary endpoint is a composite of major adverse cardiovascular events as well as major bleeding events.
After the STOP DAPT trial showed that 3 months of DAPT after PCI was as safe as prolonged DAPT in patients receiving a everolimus-eluting chromium-cobalt stent (Cardiovasc Interv Ther. 2016;31:196-209), the same group of Japanese investigators conceived the STOP-DAPT2 trial. In this trial, 3,000 patients are being randomized a standard DAPT or clopidogrel monotherapy beginning 1 month after PCI. The primary outcome is similar to that of SMART-CHOICE.
In yet another trial cited by Dr. Serruys, patients will receive DAPT only if the PCI outcome is considered suboptimal. For those judged to have a good result, patients will receive ticagrelor alone. Outcomes at the end of 1 year will be monitored.
The movement toward antiplatelet monotherapy is driven by recognition that “the need to mitigate the risk of bleeding is an important as the need to mitigate thrombosis,” Dr. Baber explained. Like Dr. Serruys, he believes it is important to challenge the standard.
“By testing single, specific, and potent antiplatelet therapy and getting rid of the old and nonspecific platelet drug called acetylsalicylic acid, we may be able to simplify risk management after PCI,” agreed Dr. Serruys. If, as expected, the GLOBAL LEADERS and other monotherapy antiplatelet trials meet their endpoints, it will mean a major evolution in postprocedural risk management.
Dr. Serruys reported no financial relationships to disclose.
WASHINGTON – Guidelines were recently modified to permit shorter duration of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention, but a series of ongoing trials are evaluating whether DAPT can be abandoned altogether in many if not most percutaneous coronary intervention (PCI) patients, according to a review of this major potential change in direction presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“The 1-year duration of dual-antiplatelet therapy post PCI with a drug eluting stent is based on anecdotal historical data,” asserted Patrick W. Serruys, MD, PhD, professor of cardiology, Imperial College, London. Citing several sets of data consistent with the conclusion that single agents provide adequate protection against thrombus formation but reduced risk of bleeding relative to DAPT, he suggested that it is now critical to challenge the old standard.
It has long been understood that greater protection against thrombus formation with more aggressive antiplatelet therapy is purchased with a higher risk of bleeding, but there appears to be a fundamental change in orientation. Several new pieces of evidence, including data showing that shorter duration of DAPT is as good as longer duration, has placed this trade-off in doubt at least over the longer term.
To some degree, the current standard was based on the premise that thrombotic events are more important than bleeding events, according to Usman Baber, MD, assistant professor of cardiology, Icahn School of Medicine at Mount Sinai, New York. He said, “That thought process really dominated thinking for many years, but this is completely unsupported by the data.” Instead, he noted that hazard ratios after thrombotic and bleeding events are almost identical, but the risk of death after bleeding is more persistent, while risk of ischemic events typically diminishes after an initial peak.
There is no shortage of studies that have attempted to determine the ideal combination and duration of antiplatelet therapies after PCI, but the heterogeneity of study design has prohibited definitive conclusions. In particular, Dr. Serruys suggested that there is no level 1 evidence confirming the value of adding aspirin, which he emphasized has a relatively nonspecific effect, over that of P2Y12 inhibitor alone.
In the design phase of the GLOBAL LEADERS trial, Dr. Serruys recounted, he first argued for a design in which aspirin was eliminated altogether and then for a protocol with only a single week of aspirin, but was met with strong objections each time. In the end, the experimental protocol calls for 1 month of aspirin plus ticagrelor before patients are continued on ticagrelor alone. This is being compared with the current standard, which is aspirin plus ticagrelor or clopidogrel for 12 months followed by another 12 months of aspirin alone.
GLOBAL LEADERS is an all-comers trial in which patients are randomized before PCI. All patients at the 131 participating centers in 18 countries are receiving the same stent (BioMatrix Flex). The primary endpoint is all-cause mortality, and enrollment is completed. The results are expected in November of this year.
There are numerous other studies addressing the same question. Like GLOBAL LEADERS, the TWILIGHT trial is also investigator-initiated and is near the halfway mark for a 9,000-patient enrollment. In this study, patients are being randomized to aspirin plus ticagrelor or ticagrelor alone after they have achieved a successful placement of a drug-eluting stent. This trial, however, is restricted to those with diabetes, chronic kidney disease, or other high-risk features. The primary endpoint is major bleeding. Completion is expected in 2019.
The SMART-CHOICE trial is enrolling roughly 5,000 PCI patients receiving a drug-eluting stent. Patients are being randomized to a P2Y12 antagonist monotherapy plus aspirin or the P2Y12 antagonist alone. The primary endpoint is a composite of major adverse cardiovascular events as well as major bleeding events.
After the STOP DAPT trial showed that 3 months of DAPT after PCI was as safe as prolonged DAPT in patients receiving a everolimus-eluting chromium-cobalt stent (Cardiovasc Interv Ther. 2016;31:196-209), the same group of Japanese investigators conceived the STOP-DAPT2 trial. In this trial, 3,000 patients are being randomized a standard DAPT or clopidogrel monotherapy beginning 1 month after PCI. The primary outcome is similar to that of SMART-CHOICE.
In yet another trial cited by Dr. Serruys, patients will receive DAPT only if the PCI outcome is considered suboptimal. For those judged to have a good result, patients will receive ticagrelor alone. Outcomes at the end of 1 year will be monitored.
The movement toward antiplatelet monotherapy is driven by recognition that “the need to mitigate the risk of bleeding is an important as the need to mitigate thrombosis,” Dr. Baber explained. Like Dr. Serruys, he believes it is important to challenge the standard.
“By testing single, specific, and potent antiplatelet therapy and getting rid of the old and nonspecific platelet drug called acetylsalicylic acid, we may be able to simplify risk management after PCI,” agreed Dr. Serruys. If, as expected, the GLOBAL LEADERS and other monotherapy antiplatelet trials meet their endpoints, it will mean a major evolution in postprocedural risk management.
Dr. Serruys reported no financial relationships to disclose.
WASHINGTON – Guidelines were recently modified to permit shorter duration of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention, but a series of ongoing trials are evaluating whether DAPT can be abandoned altogether in many if not most percutaneous coronary intervention (PCI) patients, according to a review of this major potential change in direction presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“The 1-year duration of dual-antiplatelet therapy post PCI with a drug eluting stent is based on anecdotal historical data,” asserted Patrick W. Serruys, MD, PhD, professor of cardiology, Imperial College, London. Citing several sets of data consistent with the conclusion that single agents provide adequate protection against thrombus formation but reduced risk of bleeding relative to DAPT, he suggested that it is now critical to challenge the old standard.
It has long been understood that greater protection against thrombus formation with more aggressive antiplatelet therapy is purchased with a higher risk of bleeding, but there appears to be a fundamental change in orientation. Several new pieces of evidence, including data showing that shorter duration of DAPT is as good as longer duration, has placed this trade-off in doubt at least over the longer term.
To some degree, the current standard was based on the premise that thrombotic events are more important than bleeding events, according to Usman Baber, MD, assistant professor of cardiology, Icahn School of Medicine at Mount Sinai, New York. He said, “That thought process really dominated thinking for many years, but this is completely unsupported by the data.” Instead, he noted that hazard ratios after thrombotic and bleeding events are almost identical, but the risk of death after bleeding is more persistent, while risk of ischemic events typically diminishes after an initial peak.
There is no shortage of studies that have attempted to determine the ideal combination and duration of antiplatelet therapies after PCI, but the heterogeneity of study design has prohibited definitive conclusions. In particular, Dr. Serruys suggested that there is no level 1 evidence confirming the value of adding aspirin, which he emphasized has a relatively nonspecific effect, over that of P2Y12 inhibitor alone.
In the design phase of the GLOBAL LEADERS trial, Dr. Serruys recounted, he first argued for a design in which aspirin was eliminated altogether and then for a protocol with only a single week of aspirin, but was met with strong objections each time. In the end, the experimental protocol calls for 1 month of aspirin plus ticagrelor before patients are continued on ticagrelor alone. This is being compared with the current standard, which is aspirin plus ticagrelor or clopidogrel for 12 months followed by another 12 months of aspirin alone.
GLOBAL LEADERS is an all-comers trial in which patients are randomized before PCI. All patients at the 131 participating centers in 18 countries are receiving the same stent (BioMatrix Flex). The primary endpoint is all-cause mortality, and enrollment is completed. The results are expected in November of this year.
There are numerous other studies addressing the same question. Like GLOBAL LEADERS, the TWILIGHT trial is also investigator-initiated and is near the halfway mark for a 9,000-patient enrollment. In this study, patients are being randomized to aspirin plus ticagrelor or ticagrelor alone after they have achieved a successful placement of a drug-eluting stent. This trial, however, is restricted to those with diabetes, chronic kidney disease, or other high-risk features. The primary endpoint is major bleeding. Completion is expected in 2019.
The SMART-CHOICE trial is enrolling roughly 5,000 PCI patients receiving a drug-eluting stent. Patients are being randomized to a P2Y12 antagonist monotherapy plus aspirin or the P2Y12 antagonist alone. The primary endpoint is a composite of major adverse cardiovascular events as well as major bleeding events.
After the STOP DAPT trial showed that 3 months of DAPT after PCI was as safe as prolonged DAPT in patients receiving a everolimus-eluting chromium-cobalt stent (Cardiovasc Interv Ther. 2016;31:196-209), the same group of Japanese investigators conceived the STOP-DAPT2 trial. In this trial, 3,000 patients are being randomized a standard DAPT or clopidogrel monotherapy beginning 1 month after PCI. The primary outcome is similar to that of SMART-CHOICE.
In yet another trial cited by Dr. Serruys, patients will receive DAPT only if the PCI outcome is considered suboptimal. For those judged to have a good result, patients will receive ticagrelor alone. Outcomes at the end of 1 year will be monitored.
The movement toward antiplatelet monotherapy is driven by recognition that “the need to mitigate the risk of bleeding is an important as the need to mitigate thrombosis,” Dr. Baber explained. Like Dr. Serruys, he believes it is important to challenge the standard.
“By testing single, specific, and potent antiplatelet therapy and getting rid of the old and nonspecific platelet drug called acetylsalicylic acid, we may be able to simplify risk management after PCI,” agreed Dr. Serruys. If, as expected, the GLOBAL LEADERS and other monotherapy antiplatelet trials meet their endpoints, it will mean a major evolution in postprocedural risk management.
Dr. Serruys reported no financial relationships to disclose.
EXPERT ANALYSIS FROM CRT 2017
STEMI team repurposed for rapid treatment of pulmonary emboli
WASHINGTON – The in-hospital team responsible for rapid management of ST-elevation myocardial infarction (STEMI) may also be the right team to manage pulmonary embolism (PE), according to a pilot study associating this approach with rapid treatment times and low overall mortality rates.
The data from the pilot study suggest that arming the STEMI team with a protocol for managing PE “is an effective means to care for patients with massive and submassive pulmonary embolism,” said Michael R. Kendall, MD, of the University of Southern California, Los Angeles. He presented the findings at the 2017 Cardiovascular Research Technologies meeting.
There are obvious parallels between STEMI and PE. Like STEMI, PE requires rapid diagnosis, triage, and when appropriate, an endovascular procedure. This led the USC investigators to consider a formal pilot study to test the premise that the STEMI team is in a position to deliver urgent care and good outcomes to PE patients.
The objective of the pilot study was “to evaluate treatment times and clinical outcome for patients with massive and submassive PE using a dedicated PE protocol,” Dr. Kendall explained. Massive PE was defined as hemodynamic instability with systolic blood pressure below 90 mm Hg or requiring inotropic support. Submassive PE was defined as systolic BP greater than 90 mm Hg with right heart dysfunction, such as a dilated right ventricle and elevated troponin levels.
Over an 18-month period beginning in June 2014, 40 PE patients were treated. The average age was 55 years, 50% were obese, 32% had renal insufficiency, 30% had recent surgery or had recently been immobilized, 30% had a history of deep venous thrombosis, and 28% had an active malignancy. At 43%, the largest single source of cases was the emergency department (ED), while 38% were transferred in from other centers, and 19% were already hospitalized at the time of the PE.
All patients underwent computed tomographic pulmonary angiography (CTPA) as part of the diagnostic procedure prior to an invasive angiogram. Patients received one or more different treatments upon confirmation of the PE, including catheter-directed thrombolytics, rheolytic thrombectomy, mechanical fragmentation, mechanical aspiration, and surgical pulmonary embolectomy. Inferior vena cava filters were used as appropriate.
At presentation, 10% were in cardiac arrest, 22% required intubation, and 12% required extracorporeal membrane oxygenation. On the basis of the diagnostic studies, 57% had a massive PE, and the remainder had submassive disease.
The average time from door to CTPA among those presenting to the ED was roughly 5 hours. It took, on average, an additional 2 hours from CTPA to an invasive angiogram, and another 3 hours to treatment, producing a total average door to treatment time of 10 hours.
Most patients received rheolytic thrombectomy, often with another form of treatment, such as catheter-directed thrombolytics, but 15% were treated with anticoagulation alone. Although a few patients improved sufficiently to obviate the need for an invasive procedure, the remainder of the patients received anticoagulation alone because of contraindications for invasive strategies or treatment refusal.
The average length of a hospital stay was 15 days. Bleeding events occurred in 10% of patients and 18% required a blood transfusion. Survival to hospital discharge was 82%. Although there was no control group, this rate of survival was considered favorable in the context of the severity of the PE.
Overall, delivery of urgent care for PE by a STEMI team was found feasible. Even though treatment approaches were not standardized, the protocol for diagnosing and managing PE on an urgent basis produced encouraging times for delivery of care and outcomes, according to the data presented by Dr. Kendall. Because of the differences in the composition and function of the STEMI team, Dr. Kendall indicated that it is difficult to predict similar success at other centers, but the findings overall were considered positive.
The senior author of the study, David M. Shavelle, MD, also at USC, suggested that the program there might be a template. He believes that the STEMI team has the skills to deliver prompt PE care, and he believes that this approach would be appropriate at other centers. He also suggested that such formal programs may be useful in establishing better treatment protocols.
“For PE, there are no clear guidelines for treatment time intervals, such as time from door to endovascular treatment,” Dr. Shavelle observed. He said that the wide variation of devices currently being used for treatment complicates efforts to develop clear clinical protocols and measure outcomes and “would like to see more standardization of treatment and registries to address these areas.”
Dr. Kendall reported no financial relationships.
WASHINGTON – The in-hospital team responsible for rapid management of ST-elevation myocardial infarction (STEMI) may also be the right team to manage pulmonary embolism (PE), according to a pilot study associating this approach with rapid treatment times and low overall mortality rates.
The data from the pilot study suggest that arming the STEMI team with a protocol for managing PE “is an effective means to care for patients with massive and submassive pulmonary embolism,” said Michael R. Kendall, MD, of the University of Southern California, Los Angeles. He presented the findings at the 2017 Cardiovascular Research Technologies meeting.
There are obvious parallels between STEMI and PE. Like STEMI, PE requires rapid diagnosis, triage, and when appropriate, an endovascular procedure. This led the USC investigators to consider a formal pilot study to test the premise that the STEMI team is in a position to deliver urgent care and good outcomes to PE patients.
The objective of the pilot study was “to evaluate treatment times and clinical outcome for patients with massive and submassive PE using a dedicated PE protocol,” Dr. Kendall explained. Massive PE was defined as hemodynamic instability with systolic blood pressure below 90 mm Hg or requiring inotropic support. Submassive PE was defined as systolic BP greater than 90 mm Hg with right heart dysfunction, such as a dilated right ventricle and elevated troponin levels.
Over an 18-month period beginning in June 2014, 40 PE patients were treated. The average age was 55 years, 50% were obese, 32% had renal insufficiency, 30% had recent surgery or had recently been immobilized, 30% had a history of deep venous thrombosis, and 28% had an active malignancy. At 43%, the largest single source of cases was the emergency department (ED), while 38% were transferred in from other centers, and 19% were already hospitalized at the time of the PE.
All patients underwent computed tomographic pulmonary angiography (CTPA) as part of the diagnostic procedure prior to an invasive angiogram. Patients received one or more different treatments upon confirmation of the PE, including catheter-directed thrombolytics, rheolytic thrombectomy, mechanical fragmentation, mechanical aspiration, and surgical pulmonary embolectomy. Inferior vena cava filters were used as appropriate.
At presentation, 10% were in cardiac arrest, 22% required intubation, and 12% required extracorporeal membrane oxygenation. On the basis of the diagnostic studies, 57% had a massive PE, and the remainder had submassive disease.
The average time from door to CTPA among those presenting to the ED was roughly 5 hours. It took, on average, an additional 2 hours from CTPA to an invasive angiogram, and another 3 hours to treatment, producing a total average door to treatment time of 10 hours.
Most patients received rheolytic thrombectomy, often with another form of treatment, such as catheter-directed thrombolytics, but 15% were treated with anticoagulation alone. Although a few patients improved sufficiently to obviate the need for an invasive procedure, the remainder of the patients received anticoagulation alone because of contraindications for invasive strategies or treatment refusal.
The average length of a hospital stay was 15 days. Bleeding events occurred in 10% of patients and 18% required a blood transfusion. Survival to hospital discharge was 82%. Although there was no control group, this rate of survival was considered favorable in the context of the severity of the PE.
Overall, delivery of urgent care for PE by a STEMI team was found feasible. Even though treatment approaches were not standardized, the protocol for diagnosing and managing PE on an urgent basis produced encouraging times for delivery of care and outcomes, according to the data presented by Dr. Kendall. Because of the differences in the composition and function of the STEMI team, Dr. Kendall indicated that it is difficult to predict similar success at other centers, but the findings overall were considered positive.
The senior author of the study, David M. Shavelle, MD, also at USC, suggested that the program there might be a template. He believes that the STEMI team has the skills to deliver prompt PE care, and he believes that this approach would be appropriate at other centers. He also suggested that such formal programs may be useful in establishing better treatment protocols.
“For PE, there are no clear guidelines for treatment time intervals, such as time from door to endovascular treatment,” Dr. Shavelle observed. He said that the wide variation of devices currently being used for treatment complicates efforts to develop clear clinical protocols and measure outcomes and “would like to see more standardization of treatment and registries to address these areas.”
Dr. Kendall reported no financial relationships.
WASHINGTON – The in-hospital team responsible for rapid management of ST-elevation myocardial infarction (STEMI) may also be the right team to manage pulmonary embolism (PE), according to a pilot study associating this approach with rapid treatment times and low overall mortality rates.
The data from the pilot study suggest that arming the STEMI team with a protocol for managing PE “is an effective means to care for patients with massive and submassive pulmonary embolism,” said Michael R. Kendall, MD, of the University of Southern California, Los Angeles. He presented the findings at the 2017 Cardiovascular Research Technologies meeting.
There are obvious parallels between STEMI and PE. Like STEMI, PE requires rapid diagnosis, triage, and when appropriate, an endovascular procedure. This led the USC investigators to consider a formal pilot study to test the premise that the STEMI team is in a position to deliver urgent care and good outcomes to PE patients.
The objective of the pilot study was “to evaluate treatment times and clinical outcome for patients with massive and submassive PE using a dedicated PE protocol,” Dr. Kendall explained. Massive PE was defined as hemodynamic instability with systolic blood pressure below 90 mm Hg or requiring inotropic support. Submassive PE was defined as systolic BP greater than 90 mm Hg with right heart dysfunction, such as a dilated right ventricle and elevated troponin levels.
Over an 18-month period beginning in June 2014, 40 PE patients were treated. The average age was 55 years, 50% were obese, 32% had renal insufficiency, 30% had recent surgery or had recently been immobilized, 30% had a history of deep venous thrombosis, and 28% had an active malignancy. At 43%, the largest single source of cases was the emergency department (ED), while 38% were transferred in from other centers, and 19% were already hospitalized at the time of the PE.
All patients underwent computed tomographic pulmonary angiography (CTPA) as part of the diagnostic procedure prior to an invasive angiogram. Patients received one or more different treatments upon confirmation of the PE, including catheter-directed thrombolytics, rheolytic thrombectomy, mechanical fragmentation, mechanical aspiration, and surgical pulmonary embolectomy. Inferior vena cava filters were used as appropriate.
At presentation, 10% were in cardiac arrest, 22% required intubation, and 12% required extracorporeal membrane oxygenation. On the basis of the diagnostic studies, 57% had a massive PE, and the remainder had submassive disease.
The average time from door to CTPA among those presenting to the ED was roughly 5 hours. It took, on average, an additional 2 hours from CTPA to an invasive angiogram, and another 3 hours to treatment, producing a total average door to treatment time of 10 hours.
Most patients received rheolytic thrombectomy, often with another form of treatment, such as catheter-directed thrombolytics, but 15% were treated with anticoagulation alone. Although a few patients improved sufficiently to obviate the need for an invasive procedure, the remainder of the patients received anticoagulation alone because of contraindications for invasive strategies or treatment refusal.
The average length of a hospital stay was 15 days. Bleeding events occurred in 10% of patients and 18% required a blood transfusion. Survival to hospital discharge was 82%. Although there was no control group, this rate of survival was considered favorable in the context of the severity of the PE.
Overall, delivery of urgent care for PE by a STEMI team was found feasible. Even though treatment approaches were not standardized, the protocol for diagnosing and managing PE on an urgent basis produced encouraging times for delivery of care and outcomes, according to the data presented by Dr. Kendall. Because of the differences in the composition and function of the STEMI team, Dr. Kendall indicated that it is difficult to predict similar success at other centers, but the findings overall were considered positive.
The senior author of the study, David M. Shavelle, MD, also at USC, suggested that the program there might be a template. He believes that the STEMI team has the skills to deliver prompt PE care, and he believes that this approach would be appropriate at other centers. He also suggested that such formal programs may be useful in establishing better treatment protocols.
“For PE, there are no clear guidelines for treatment time intervals, such as time from door to endovascular treatment,” Dr. Shavelle observed. He said that the wide variation of devices currently being used for treatment complicates efforts to develop clear clinical protocols and measure outcomes and “would like to see more standardization of treatment and registries to address these areas.”
Dr. Kendall reported no financial relationships.
AT THE 2017 CRT MEETING
Key clinical point: The same team assembled for rapid response to STEMI can also treat PE, according to a pilot study.
Major finding: In the initial series of patients, of whom 57% had massive PE, in-hospital mortality was 11%.
Data source: A nonrandomized prospective analysis.
Disclosures: Dr. Kendall reported no financial relationships.
Robotic PCI success rates higher with radial access
WASHINGTON – The clinical and technical success rates are higher among patients undergoing robotic percutaneous coronary interventions through radial than femoral access, according to registry data presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Although both the clinical and technical success rates were high with either type of access, the advantage for radial over femoral access was significant for each, reported Ali Pourdjabbar, MD, an interventional cardiologist completing his fellowship at the University of California, San Diego. However, as this was not a randomized trial, he placed emphasis on the message that robotic percutaneous coronary intervention (PCI) is safe and effective when performed through either access point.
Clinical success, defined as less than 30% residual occlusion with TIMI3 flow and no major adverse cardiovascular events, such as myocardial infarction, cardiovascular death, or revascularization, was achieved in 99.4% of the 310 patients treated through radial access and 94.7% of the 191 patients treated through femoral access (P = .002). Technical success, defined as PCI performed without any manual assistance, was achieved in 92.4% of procedures performed through radial access and 86.7% of those performed through femoral access (P = .03).
There were no significant differences in the two groups for contrast use or fluoroscopy time, but the time to completing PCI was shorter with the radial approach (57 vs. 66 minutes; P less than .04).
However, the groups did differ in baseline characteristics, according to Dr. Pourdjabbar. Patients undergoing robotic PCI through a radial approach were younger, less likely to have diabetes, and less likely to have received a prior PCI. Most importantly, they were less likely to have complex lesions. Patients treated with radial access had higher average body mass indexes.
“It is important to recognize that this was a nonrandomized, retrospective analysis,” Dr. Pourdjabbar emphasized. He noted that one reason for this analysis was to confirm that efficacy and safety was just as good with radial access, which although an approved robotic approach, was supported with fewer data at the time that the device became available.
However, it is notable that 60% of the robotic procedures were done with the radial approach, which is approximately double the proportion currently performed in the United States when done manually, according to data presented by Dr. Pourdjabbar. He noted that radial access has been more commonly used outside of the United States, but rates have also started climbing in this country, rising from less than 5% of cases in 2005 to nearly one third of cases in the most recent analysis. It is unclear why robotic procedures are performed more frequently through radial access, but Dr. Pourdjabbar speculated that centers innovating with robots might also be in the vanguard of the movement toward radial PCI.
Of reasons to consider robots, Dr. Pourdjabbar suggested that the safety advantages for the interventionalist are particularly compelling. Citing a variety of data associating cath lab radiation exposure to health risks for physicians and staff, Dr. Pourdjabbar explained that the operator performs robotic PCI from a shielded cockpit that completely eliminates exposure to radiation. A next generation robotic device, called the CorPath GRX System, is expected to further reduce opportunities for radiation exposure by allowing the operator to disengage the guide catheter in cases when this had to be done manually with the first generation CorPath 200 system.
Asked about the learning curve of PCI robotics, Dr. Pourdjabbar said that the principles appear to be grasped quickly by interventionalists, but he acknowledged that his experience as a training fellow has been limited. However, Rajesh V. Swaminathan, MD, an interventionalist affiliated with Duke University, Durham, N.C., who has experience with robotic PCI, reported that although the tactile sense of the guide wire is lost in robotic PCI, the procedure has typically proceeded more quickly in his hands once access is achieved.
“The greatest learning curve may with the staff that has to get used to not having the interventionalist at the table,” observed Dr. Swaminathan, who was a moderator of the session in which these data were presented.
WASHINGTON – The clinical and technical success rates are higher among patients undergoing robotic percutaneous coronary interventions through radial than femoral access, according to registry data presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Although both the clinical and technical success rates were high with either type of access, the advantage for radial over femoral access was significant for each, reported Ali Pourdjabbar, MD, an interventional cardiologist completing his fellowship at the University of California, San Diego. However, as this was not a randomized trial, he placed emphasis on the message that robotic percutaneous coronary intervention (PCI) is safe and effective when performed through either access point.
Clinical success, defined as less than 30% residual occlusion with TIMI3 flow and no major adverse cardiovascular events, such as myocardial infarction, cardiovascular death, or revascularization, was achieved in 99.4% of the 310 patients treated through radial access and 94.7% of the 191 patients treated through femoral access (P = .002). Technical success, defined as PCI performed without any manual assistance, was achieved in 92.4% of procedures performed through radial access and 86.7% of those performed through femoral access (P = .03).
There were no significant differences in the two groups for contrast use or fluoroscopy time, but the time to completing PCI was shorter with the radial approach (57 vs. 66 minutes; P less than .04).
However, the groups did differ in baseline characteristics, according to Dr. Pourdjabbar. Patients undergoing robotic PCI through a radial approach were younger, less likely to have diabetes, and less likely to have received a prior PCI. Most importantly, they were less likely to have complex lesions. Patients treated with radial access had higher average body mass indexes.
“It is important to recognize that this was a nonrandomized, retrospective analysis,” Dr. Pourdjabbar emphasized. He noted that one reason for this analysis was to confirm that efficacy and safety was just as good with radial access, which although an approved robotic approach, was supported with fewer data at the time that the device became available.
However, it is notable that 60% of the robotic procedures were done with the radial approach, which is approximately double the proportion currently performed in the United States when done manually, according to data presented by Dr. Pourdjabbar. He noted that radial access has been more commonly used outside of the United States, but rates have also started climbing in this country, rising from less than 5% of cases in 2005 to nearly one third of cases in the most recent analysis. It is unclear why robotic procedures are performed more frequently through radial access, but Dr. Pourdjabbar speculated that centers innovating with robots might also be in the vanguard of the movement toward radial PCI.
Of reasons to consider robots, Dr. Pourdjabbar suggested that the safety advantages for the interventionalist are particularly compelling. Citing a variety of data associating cath lab radiation exposure to health risks for physicians and staff, Dr. Pourdjabbar explained that the operator performs robotic PCI from a shielded cockpit that completely eliminates exposure to radiation. A next generation robotic device, called the CorPath GRX System, is expected to further reduce opportunities for radiation exposure by allowing the operator to disengage the guide catheter in cases when this had to be done manually with the first generation CorPath 200 system.
Asked about the learning curve of PCI robotics, Dr. Pourdjabbar said that the principles appear to be grasped quickly by interventionalists, but he acknowledged that his experience as a training fellow has been limited. However, Rajesh V. Swaminathan, MD, an interventionalist affiliated with Duke University, Durham, N.C., who has experience with robotic PCI, reported that although the tactile sense of the guide wire is lost in robotic PCI, the procedure has typically proceeded more quickly in his hands once access is achieved.
“The greatest learning curve may with the staff that has to get used to not having the interventionalist at the table,” observed Dr. Swaminathan, who was a moderator of the session in which these data were presented.
WASHINGTON – The clinical and technical success rates are higher among patients undergoing robotic percutaneous coronary interventions through radial than femoral access, according to registry data presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Although both the clinical and technical success rates were high with either type of access, the advantage for radial over femoral access was significant for each, reported Ali Pourdjabbar, MD, an interventional cardiologist completing his fellowship at the University of California, San Diego. However, as this was not a randomized trial, he placed emphasis on the message that robotic percutaneous coronary intervention (PCI) is safe and effective when performed through either access point.
Clinical success, defined as less than 30% residual occlusion with TIMI3 flow and no major adverse cardiovascular events, such as myocardial infarction, cardiovascular death, or revascularization, was achieved in 99.4% of the 310 patients treated through radial access and 94.7% of the 191 patients treated through femoral access (P = .002). Technical success, defined as PCI performed without any manual assistance, was achieved in 92.4% of procedures performed through radial access and 86.7% of those performed through femoral access (P = .03).
There were no significant differences in the two groups for contrast use or fluoroscopy time, but the time to completing PCI was shorter with the radial approach (57 vs. 66 minutes; P less than .04).
However, the groups did differ in baseline characteristics, according to Dr. Pourdjabbar. Patients undergoing robotic PCI through a radial approach were younger, less likely to have diabetes, and less likely to have received a prior PCI. Most importantly, they were less likely to have complex lesions. Patients treated with radial access had higher average body mass indexes.
“It is important to recognize that this was a nonrandomized, retrospective analysis,” Dr. Pourdjabbar emphasized. He noted that one reason for this analysis was to confirm that efficacy and safety was just as good with radial access, which although an approved robotic approach, was supported with fewer data at the time that the device became available.
However, it is notable that 60% of the robotic procedures were done with the radial approach, which is approximately double the proportion currently performed in the United States when done manually, according to data presented by Dr. Pourdjabbar. He noted that radial access has been more commonly used outside of the United States, but rates have also started climbing in this country, rising from less than 5% of cases in 2005 to nearly one third of cases in the most recent analysis. It is unclear why robotic procedures are performed more frequently through radial access, but Dr. Pourdjabbar speculated that centers innovating with robots might also be in the vanguard of the movement toward radial PCI.
Of reasons to consider robots, Dr. Pourdjabbar suggested that the safety advantages for the interventionalist are particularly compelling. Citing a variety of data associating cath lab radiation exposure to health risks for physicians and staff, Dr. Pourdjabbar explained that the operator performs robotic PCI from a shielded cockpit that completely eliminates exposure to radiation. A next generation robotic device, called the CorPath GRX System, is expected to further reduce opportunities for radiation exposure by allowing the operator to disengage the guide catheter in cases when this had to be done manually with the first generation CorPath 200 system.
Asked about the learning curve of PCI robotics, Dr. Pourdjabbar said that the principles appear to be grasped quickly by interventionalists, but he acknowledged that his experience as a training fellow has been limited. However, Rajesh V. Swaminathan, MD, an interventionalist affiliated with Duke University, Durham, N.C., who has experience with robotic PCI, reported that although the tactile sense of the guide wire is lost in robotic PCI, the procedure has typically proceeded more quickly in his hands once access is achieved.
“The greatest learning curve may with the staff that has to get used to not having the interventionalist at the table,” observed Dr. Swaminathan, who was a moderator of the session in which these data were presented.
AT CRT 2017
Key clinical point: Registry data shows higher success rate for radial versus femoral access in robotic percutaneous coronary interventions.
Major finding: In robotic PCI, the clinical success rate was 99.4% with radial access and 94.7% (P = .002) with femoral access.
Data source: A nonrandomized, retrospective analysis.
Disclosures: Dr. Pourdjabbar reported no financial relationships to disclose.